Clinical Study on Chaiqin Xiaoyong Decoction （柴芩消痈饮） Combined with Jinhuang Ointment （金黄膏） for the Nodular Stage of Acne Mastitis of Liver Meridian Heat Accumulation Type：A Randomized，Double-Blind，Placebo-Controlled Trial
10.13288/j.11-2166/r.2025.09.009
- VernacularTitle:柴芩消痈饮联合金黄膏治疗肝经蕴热型粉刺性乳痈肿块期的随机、双盲、安慰剂对照临床研究
- Author:
Tian MENG
1
;
Feifei MA
1
;
Yuanyuan KANG
2
;
Mengfei SHEN
1
;
Shengfang HU
1
;
Meina YE
1
;
Yiqin CHENG
1
;
Hongfeng CHEN
1
Author Information
1. Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine，Shanghai，200032
2. Ruijin Hospital， Shanghai Jiaotong University School of Medicine
- Publication Type:Journal Article
- Keywords:
acne mastitis;
Chaiqin Xiaoyong Decoction （柴芩消痈饮）;
Jinhuang Ointment;
liver meridian heat accumulation;
randomize-controlled trial
- From:
Journal of Traditional Chinese Medicine
2025;66(9):920-926
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo evaluate the clinical efficacy and safety of the traditional Chinese medicine （TCM） compound Chaiqin Xiaoyong Decoction （柴芩消痈饮， CXD） combined with Jinhuang Ointment （金黄膏， JO） in treating the nodular stage of acne mastitis of liver meridian heat accumulation type. MethodsA randomized， double-blind， placebo-controlled clinical trial was conducted. A total of 108 patients with liver meridian heat accumulation type acne mastitis in the nodular stage were randomly assigned to a treatment group and a control group， with 54 patients in each group. Both groups received topical application of JO once daily at a thickness of 3~5 mm for 8 hours， along with standard nursing care. On this basis， the treatment group received oral CXD granules， while the control group received placebo granules， administered twice daily， 3 sachets per dose， for 14 consecutive days. Clinical efficacy， TCM symptom scores， nodule size， visual analogue scale （VAS） pain scores， white blood cell （WBC） count， C-reactive protein （CRP） level， and systemic immune-inflammation index （SII） were compared. At the end of treatment， efficacy and safety indicators were evaluated. A 6-month follow-up was conducted to compare the proportion of patients undergoing surgical treatment. ResultsThe total clinical efficacy rate in the treatment group was 90.38% （47/52）， significantly higher than 32.00% （16/50） in the control group （P＜0.01）. The treatment group also showed significantly lower TCM symptom scores， VAS scores， nodule size， WBC count， CRP level， and SII （P＜0.05 or P＜0.01）. During follow-up， the surgical intervention rate in the treatment group was 5.77% （3/52）， lower than 14.00% （7/50） in the control group， with a statistically significant difference （P＜0.01）. No significant abnormalities were observed in safety indicators before and after treatment in either group. ConclusionCXD effectively reduces nodule size and alleviates symptoms such as redness and pain in patients with acne mastitis of liver meridian heat accumulation type， improves TCM symptom scores， enhances overall clinical efficacy， and demonstrates good safety.
